Comparing Colchicine with Dapsone for primary cutaneous vasculitis

Exclusion

• −History of significant intolerance, allergy or serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → to any of the study medications: such patients can be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → directly in the second stage of the study and be randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to receive one of the two other study drugs. The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%).
• −Presence of significant extra-cutaneous manifestations suggestive of a systemic vasculitis or more diffuse condition. The presence of mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia \[Hb ≥ 10 g/dL\] are not exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →. Mild and stable microscopic hematuria without RBC casts and/or mild and stable proteinuria (\<1g/24 hours) are not exclusion criteria. These latter patients must not require systemic immunosuppressive therapy because of possible renal involvement and their GFR must be \>60 ml/min.
• −Known systemic and/or non-skin-isolated vasculitis, such as granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, systemic polyarteritis nodosa, central nervous system vasculitis and patients with detectable antineutrophil cytoplasmic antibody (ANCA) by immunofluorescence or ELISA.
• −Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides such as those secondary to systemic lupus erythematosus, Sjögren syndrome, another auto-immune condition, a cancer, a hematological disorder, an ongoing active infection, or an ongoing medication. Investigators should consider such underlying diagnoses and perform and interpret appropriate laboratory work-up where indicated based on clinical presentation.
• −Patients who have contra-indications to two or three of the study drugs (azathioprine, colchicine, or dapsone), or have been treated prior to enrollment with two or three of the study drugs but failed to respond to them, or had to stop two or three of them because of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →.
• −Deficit in glucose-6-phosphate dehydrogenase (G6PD) or history of hemolytic anemia (all patients must be tested for G6PD at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more → to assess for their eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →): such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (azathioprine or colchicine). The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%).
• −Low or absent thiopurine methyltransferase (TPMT) activity (if known, not a requirement for study entry): Patients known to have low or absent TPMT can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (dapsone or colchicine).
• −Evidence of significant hepatic insufficiency or liver function tests \> 2 times the upper limit of normal.
• −Evidence of significant renal insufficiency or creatinine clearance \< 60 mL/min.
• −Evidence of significant or symptomatic anemia or Hb \< 10 g/dL.
• −Comorbid condition that has moderate or high likelihood of requiring intermittent courses of prednisone within the study period, according to the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (e.g. chronic obstructive pulmonary disease (COPD), unstable or severe asthma).
• −Active cancer or history of malignancy within the previous 5 years (patient in remission of a cancer \>5 years, or with non-metastatic prostate cancer or treated basal or squamous cell carcinoma of the skin can be enrolled).
• −Active uncontrolled or serious infection that may compromise or contra-indicate the use of the study medications.
• −Patient unable to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• −Pregnant or lactating women.